ContraceptionHAPPINCT06823037
Hormonal Contraception Access Through Pharmacist Prescribing Implementation
A study testing HAPPI software in people with Contraception and Pharmaceutical Services, run by EMPOWERX INC at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if use of the HAPPI software can improve pharmacist-provided birth control services. The main questions it aims to answer are: 1. Does the HAPPI software make it easier for pharmacists to provide birth control services in their pharmacy? 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contraception, Pharmaceutical Services, Access and Linkage to Healthcare
- What is being tested?
- HAPPI software
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2025to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Provide birth control services in a participating pharmacy
- Use the HAPPI software to provide birth control services
- 18 years of age or older
- Seek birth control services at a participating pharmacy
- Use the HAPPI software to receive birth control services at a participating pharmacy
Who cannot join
- None
- PATIENT Participants
- NONE
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sally Rafie, PharmD contact
United States1 site, 1 recruiting
- Recruiting
EmpoweRx, Inc
Del Mar, California, 92014
Sally Rafie, PharmD, 8584120984, mail@birthcontrolpharmacist.com
About this study
Official title: HAPPI (Hormonal Contraception Access Through Pharmacist Prescribing Implementation): Phase 2 (Aim 1)
The goal of this clinical trial is to learn if use of the HAPPI software can improve pharmacist-provided birth control services. The main questions it aims to answer are:
- Does the HAPPI software make it easier for pharmacists to provide birth control services in their pharmacy?
- Does the HAPPI software make it easier for patients to access birth control?
Read more
Researchers will compare pharmacists' implementation and patients' access when using the HAPPI software and when not using the HAPPI software to see if the software improves implementation and access.
Participants will include pharmacists and patients. Pharmacists will be asked to provide birth control services as normal while using the HAPPI software. Patients will be asked to receive birth control services from a pharmacist as normal, while using the HAPPI software.
- Being tested
- HAPPI software
- Keywords
- community pharmacy, access to care, pharmacist services, birth control, health technology, scope of practice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HAPPI softwareOther
We will enroll 15 community pharmacies. These 15 pharmacies will continue to provide birth control services as normal for several months (control).
Then, we will introduce the intervention: the HAPPI software. The pharmacies will continue to provide birth control services while using the HAPPI software in place of any paper or electronic processes that they were previously using. The results will then be compared between the control and the intervention period.
| Study group | Role | What they receive |
|---|---|---|
| HAPPI Pharmacies | Other | This is a single-arm trial, so all pharmacies will serve as their own control. We will enroll 15 community pharmacies. These 15 pharmacies will continue to provide birth control services as normal for several months (control). Then, we will introduce the intervention: the HAPPI software. The pharmacies will continue to provide birth control services while using the HAPPI software in place of any paper or electronic processes that they were previously using. The results will then be compared between the control and the intervention period. Receives: Other: HAPPI software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implementation - Service Characteristics Number of Pharmacists
Implementation outcomes will focus on how the service (pharmacist-prescribed contraceptive services) is implemented.
Name of the Measurement: Implementation - Service Characteristics Measurement Tool: Pharmacy Service Characteristics Questionnaire
Unit of Measure:
- Number of pharmacists involved in providing birth control services
Measured: up to 5 months
Implementation - Service Characteristics Number of Pharmacy Staff
Implementation outcomes will focus on how the service (pharmacist-prescribed contraceptive services) is implemented.
Name of the Measurement: Implementation - Service Characteristics Measurement Tool: Pharmacy Service Characteristics Questionnaire
Unit of Measure:
- Number of pharmacy staff (non-pharmacists) involved in providing birth control services
Measured: up to 5 months
Implementation - Service Characteristics Cash Pay
Implementation outcomes will focus on how the service (pharmacist-prescribed contraceptive services) is implemented.
Name of the Measurement: Implementation - Service Characteristics Measurement Tool: Pharmacy Service Characteristics Questionnaire
Unit of Measure:
- Total amount of money coming in (revenue) from the service via cash pay
Measured: up to 5 months
Implementation - Service Characteristics Insurance Billing
Implementation outcomes will focus on how the service (pharmacist-prescribed contraceptive services) is implemented.
Name of the Measurement: Implementation - Service Characteristics Measurement Tool: Pharmacy Service Characteristics Questionnaire
Unit of Measure:
- Total amount of money coming in (revenue) from the service via insurance billing
Measured: up to 5 months
Implementation - Proctor Implementation Outcomes
Implementation outcomes will be measured using Proctor et al.'s (2011) implementation framework. The domains in this framework include appropriateness, acceptability, adoption, feasibility, and fidelity. Survey items will map to each of these domains.
Name of the measurement: Implementation - Proctor Implementation Outcomes Measurement tool: Implementation Outcomes Scale Unit of Measure: 5-point Likert-type scale (1= strongly disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, 5 = strongly agree). This same scale is used for all implementation domains (appropriateness, acceptability, adoption, feasibility, and fidelity).
Measured: up to 5 months
Secondary outcomes (1)
Access to Care
Access to Care outcomes will be assessed using a previously developed scale of Access to Contraceptive Care (Newlon 2021) that assesses patients' access in terms of approachability, acceptability, availability and accommodation, affordability, appropriateness, and privacy.
Unite of measure: 5-point Likert-type scale (1= strongly disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, 5 = strongly agree). This same scale is used for all implementation domains (approachability, acceptability, availability and accommodation, affordability, appropriateness, and privacy).
Measured: up to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start9 Oct 2025
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EMPOWERX INC
- Sponsor type
- University, hospital or other
- Collaborators
- Purdue University
- Responsible party
- Principal investigator, Jenny Newlon, EMPOWERX INC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06823037
- Sponsor's protocol ID
- R44DP006691
- Acronym
- HAPPI
- Status last verified
- Dec 2025
- First submitted
- 20 Jan 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Our clinical trial uses proprietary information related to the software that is the basis for our intervention. We will need to find a way to ensure we protect all intellectual property and proprietary information before we develop a plan to share IPD.
Publications
Newlon JL, Campi JA, Rafie S, Meredith AH. Determining user implementation needs for pharmacist-prescribed contraception using concept mapping: A participatory, multiple stakeholder approach. Explor Res Clin Soc Pharm. 2024 Oct 11;16:100525. doi: 10.1016/j.rcsop.2024.100525. eCollection 2024 Dec.
PubMed 39512515Campi JA, Rafie S, Newlon JL, Meredith AH. Implementation of pharmacist-prescribed contraceptive services: A case series of early adopters. JAPhA Pract Innov. 2024 Jul;1(3):100011. doi: 10.1016/j.japhpi.2024.100011. Epub 2024 Apr 20.
PubMed 39420991
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HAPPI (Hormonal Contraception Access Through Pharmacist Prescribing Implementation): Phase 2 (Aim 1)
- ClinicalTrials.gov ID
- NCT06823037
- Acronym / sponsor ID
- HAPPI / R44DP006691
- Keywords
- community pharmacy, access to care, pharmacist services, birth control, health technology, scope of practice
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- EMPOWERX INCUniversity, hospital or other
- Collaborators
- Purdue University
- Study start
- 9 Oct 2025 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 12 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if use of the HAPPI software can improve pharmacist-provided birth control services. The main questions it aims to answer are:
- Does the HAPPI software make it easier for pharmacists to provide birth control services in their pharmacy?
- Does the HAPPI software make it easier for patients to access birth control?
Researchers will compare pharmacists' implementation and patients' access when using the HAPPI software and when not using the HAPPI software to see if the software improves implementation and access.
Participants will include pharmacists and patients. Pharmacists will be asked to provide birth control services as normal while using the HAPPI software. Patients will be asked to receive birth control services from a pharmacist as normal, while using the HAPPI software.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HAPPI Pharmacies | Other | Other: HAPPI softwareThis is a single-arm trial, so all pharmacies will serve as their own control. We will enroll 15 community pharmacies. These 15 pharmacies will continue to provide birth control services as normal for several months (control). Then, we will introduce the intervention: the HAPPI software. The pharmacies will continue to provide birth control services while using the HAPPI software in place of any paper or electronic processes that they were previously using. The results will then be compared between the control and the intervention period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age or older
- Provide birth control services in a participating pharmacy
- Use the HAPPI software to provide birth control services
- 18 years of age or older
- Seek birth control services at a participating pharmacy
Key exclusion criteria (3 listed)
- None
- PATIENT Participants
- NONE
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HAPPI softwareWe will enroll 15 community pharmacies. These 15 pharmacies will continue to provide birth control services as normal for several months (control). Then, we will introduce the intervention: the HAPPI software. The pharmacies will continue to provide birth control services while using the HAPPI software in place of any paper or electronic processes that they were previously using. The results will then be compared between the control and the intervention period. | Other | HAPPI Pharmacies |
Primary outcome
Implementation - Service Characteristics Number of Pharmacists
Time frame: up to 5 months
Implementation outcomes will focus on how the service (pharmacist-prescribed contraceptive services) is implemented. Name of the Measurement: Implementation - Service Characteristics Measurement Tool: Pharmacy Service Characteristics Questionnaire Unit of Measure: * Number of pharmacists involved in providing birth control services
Implementation - Service Characteristics Number of Pharmacy Staff
Time frame: up to 5 months
Implementation outcomes will focus on how the service (pharmacist-prescribed contraceptive services) is implemented. Name of the Measurement: Implementation - Service Characteristics Measurement Tool: Pharmacy Service Characteristics Questionnaire Unit of Measure: * Number of pharmacy staff (non-pharmacists) involved in providing birth control services
Implementation - Service Characteristics Cash Pay
Time frame: up to 5 months
Implementation outcomes will focus on how the service (pharmacist-prescribed contraceptive services) is implemented. Name of the Measurement: Implementation - Service Characteristics Measurement Tool: Pharmacy Service Characteristics Questionnaire Unit of Measure: * Total amount of money coming in (revenue) from the service via cash pay
Implementation - Service Characteristics Insurance Billing
Time frame: up to 5 months
Implementation outcomes will focus on how the service (pharmacist-prescribed contraceptive services) is implemented. Name of the Measurement: Implementation - Service Characteristics Measurement Tool: Pharmacy Service Characteristics Questionnaire Unit of Measure: * Total amount of money coming in (revenue) from the service via insurance billing
Implementation - Proctor Implementation Outcomes
Time frame: up to 5 months
Implementation outcomes will be measured using Proctor et al.'s (2011) implementation framework. The domains in this framework include appropriateness, acceptability, adoption, feasibility, and fidelity. Survey items will map to each of these domains. Name of the measurement: Implementation - Proctor Implementation Outcomes Measurement tool: Implementation Outcomes Scale Unit of Measure: 5-point Likert-type scale (1= strongly disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, 5 = strongly agree). This same scale is used for all implementation domains (appropriateness, acceptability, adoption, feasibility, and fidelity).
1 secondary outcome
Access to Care
Time frame: up to 5 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Background: PubMed 39512515Newlon JL, Campi JA, Rafie S, Meredith AH. Determining user implementation needs for pharmacist-prescribed contraception using concept mapping: A participatory, multiple stakeholder approach. Explor Res Clin Soc Pharm. 2024 Oct 11;16:100525. doi: 10.1016/j.rcsop.2024.100525. eCollection 2024 Dec.
- Background: PubMed 39420991Campi JA, Rafie S, Newlon JL, Meredith AH. Implementation of pharmacist-prescribed contraceptive services: A case series of early adopters. JAPhA Pract Innov. 2024 Jul;1(3):100011. doi: 10.1016/j.japhpi.2024.100011. Epub 2024 Apr 20.
- Individual participant dataSharing planned: Undecided. Our clinical trial uses proprietary information related to the software that is the basis for our intervention. We will need to find a way to ensure we protect all intellectual property and proprietary information before we develop a plan to share IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sally Rafie, PharmD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HAPPI software in people with Contraception and Pharmaceutical Services, run by EMPOWERX INC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jenny L Newlon, PharmD, PhD (8584120984, jenny@birthcontrolpharmacist.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implementation - Service Characteristics Number of Pharmacists (time frame: up to 5 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06823037, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.